Utilizing Traditional Practices

NCT03164577 | Completed DMC

• 1 other identifier: 1R34AA024818-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico, co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization providing consultative services for American Indians/Alaska Natives (AI/ANs). A feasibility randomized clinical trial will be conducted within an urban setting and will compare urban AI/AN males and females with AOD disorders who receive DARTNA (n=30) to AI/AN males and females with AOD disorders who receive usual care plus (n=30). Compare outcomes at end of treatment and 3-months post-treatment to gather data that can be used to judge the feasibility of a larger trial, and to plan that trial. Obtain information on (a) clinically significant changes in AOD use, (b) clinically significant changes in mental health, physical health, spirituality, cognition, adoption of 12-step principles and practices, and cultural identification, and (c) estimate covariate correlations, reliability of measures and likely effect sizes.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (1)

• Change in alcohol and other drug use based on the Timeline Follow Back

  recent alcohol and other drug use will be tracked

  Change from baseline alcohol and other drug use at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)

Secondary Outcomes (3)

• Change in physical health status utilizing the Physical health questionnaire (PHQ)

  Change from baseline physical health status at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)

• Change in Spirituality utilizing the Functional Assessment of Chronic Illness Therapy (FACIT): Spiritual Questions Only-Expanded

  Change from baseline spirituality at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)

• Change in cognitive function utilizing the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3

  Change from baseline cognitive function at end of treatment (42-72 days) and at 3-month follow-up (132-177 days)

Study Arms (2)

DARTNA

ACTIVE COMPARATOR

DARTNA is a culturally-adaptable therapeutic drum behavior therapy that incorporates drumming, talking circles, and uses the 12 Steps of Alcoholics Anonymous (AA)/Narcotics Anonymous (NA) program within the conceptual framework of the Northern Plains Medicine Wheel. The Northern Plains Medicine Wheel is widely utilized as a conceptual framework and integrative approach to health and wellness for AI/ANs. This intervention consists of 12 sessions provided 2 times weekly over 6 weeks.

Behavioral: Drum-Assisted Recovery Therapy for Native Americans (DARTNA)

Usual care plus

PLACEBO COMPARATOR

Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants. They will engage in health and wellness education session once weekly for 6 weeks. They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.

Other: Usual Care Plus

Interventions

Drum-Assisted Recovery Therapy for Native Americans (DARTNA) BEHAVIORAL

An intervention that utilizes AI/AN drumming as its core component of treatment.

DARTNA

Usual Care Plus OTHER

Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants. They will engage in health and wellness education session once weekly for 6 weeks. They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.

Usual care plus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 30 males and 30 females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) self-identify as AI/AN male or female, (2) be seeking treatment for their drug or alcohol dependence; (3) be 18-59 years of age or older; (4) meet Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) criteria for AOD use disorders;

You may not qualify if:

• \. have a mental health or medical history that, in the judgment of the study physician or PI, show no clinically significant contraindications for study participation.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• RAND: collaborator

Study Sites (1)

United American Indian Involvement, Inc.

Los Angeles, California, 90017, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 23, 2017
• Study Start: June 1, 2017
• Primary Completion: February 20, 2019
• Study Completion: August 31, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)